# K162487: BSD3543 Digital Flat Panel X-ray Detector

- Pathway: 510(k) (Special)
- Applicant: Bontech, Inc.
- Decided: Oct 14, 2016 after 37 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K981556 (1998). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160204: BSD4343 Digital Flat Panel X-ray Detector, Bontech, Inc. (2016) Summary page 4.

## Most influential descendants
- K200787: BSD3543W (2020), 0 descendants of its own

## Indications for use
The BSD3543(BT-DA22-IA/BT-DB22-IA) detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.

Source page: https://510kreport.com/device/K162487
Methodology: https://510kreport.com/methodology